FDA Inspection
Sunnex, LLCSunnex, LLC – FDA Inspection, Jul 30, 2012
Record Details
This FDA Inspection record concerns Sunnex, LLC, with an inspection on July 30, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Sunnex, LLC
- Inspection Date
- July 30, 2012
- Product Type
- Devices
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ID · 8b7b17bc-681e-47e7-97c5-a8945dc4a38c
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 792958
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
13- 21 CFR 820.184DHR - not or inadequately maintained
- 21 CFR 820.181DMR - not or inadequately maintained
- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.198(b)Review and evaluation for investigation
- 21 CFR 820.25(a)Personnel
- 21 CFR 820.25(b)Training records
- 21 CFR 820.80(b)Lack of or inadequate receiving acceptance procedures
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.184Lack of or inadequate DHR procedures
- 21 CFR 820.90(b)(1)Procedures for product review,disposition lack of/inadequate
Showing 10 of 13 citations.
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Other FDA inspections of Sunnex, LLC
6| Date | Classification | Office | Project area |
|---|---|---|---|
| February 27, 2023 | Not classified | Atlanta District Office | |
| February 18, 2022 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| July 3, 2019 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| July 12, 2017 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| February 18, 2015 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Sunnex, LLC
- FDA Inspection 1198971 - 2023-02-27
- FDA Inspection 1162566 - 2022-02-18
- FDA Inspection 1095148 - 2019-07-03
- FDA Inspection 1017642 - 2017-07-12
- FDA Inspection 916882 - 2015-02-18
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